Manufacturer defends record, says arthritis not tied to doses

04/09/2001

Washington Post

WASHINGTON – Vanessa Raffio was a horsewoman and a veterinarian's helper who loved hiking and riding in the woods – hobbies that seemed to place the suburban New Jersey teenager at high risk for getting Lyme disease. So two years ago, Ms. Raffio, then 17, asked her doctor for the recently approved vaccine against the tick-borne infection.

"I'm the one who pushed for it," recalled her mother, Linda Scharf-Lurie. "It was the biggest mistake of my life."

Soon after she got her second dose of the vaccine in June 1999, Ms. Raffio began having pains in her ankles, she said. That autumn, she developed severe pain in her neck and backand wasfound to have rheumatoid arthritis. She also permanently lost the peripheral vision in her left eye when her optic nerve became inflamed.

These days, Ms. Raffio, now a college freshman at the University of Missouri at Columbia, can ride a horse only for brief periods and uses an electrical nerve stimulator to relieve her chronic pain.

"I have arthritis ... pretty much everywhere but my knees," she said. "I've learned to manage to the best of my ability. ... My body is not like everyone else's body."

Ms. Raffio is one of more than 100 people whose arthritis or joint swelling is being investigated by the Food and Drug Administration because of possible links to the vaccine.

Such cases, and the questions they raise about the vaccine's safety, have renewed a debate on the risks and benefits of vaccines for illnesses, such as Lyme disease, that are treatable or avoidable by other means.

"This is what some people have called a 'boutique vaccine,' " said Robert Daum, a professor of pediatrics at the University of Chicago who chaired the FDA advisory committee that reviewed the vaccine.

Sidney M. Wolfe, director of the Public Citizen Health Research Group, a consumer group, said that the "vaccine is being grossly overpromoted to people who don't live in parts of the country where ... [Lyme disease] happens very much."

Carmel Hogan, a spokeswoman for GlaxoSmithKline Inc., which makes the vaccine, defended its safety record and the company's marketing policies. The company has distributed 1.4 million doses of the vaccine and continues to sponsor follow-up research on its safety, she said.

"Based on clinical trials to date and postmarketing surveillance ... there is no causal link between this vaccine and arthritis," Ms. Hogan said.

When the FDA approved the vaccine, called LYMErix, in 1998, the agency concluded that the product was safe after reviewing extensive studies sponsored by GlaxoSmithKline, including a two-year trial involving almost 11,000 healthy adults and adolescents. Neither that study nor a separate safety trial in people with a history of Lyme disease found evidence that the vaccine could cause arthritis or other serious adverse effects.

However, members of the FDA advisory committee that reviewed LYMErix expressed concern at the time that the vaccine might have the potential to provoke arthritis in some recipients. The committee asked GlaxoSmithKline to conduct a large follow-up study after approval, and urged long-term monitoring of the health of vaccine recipients.

This year the same committee heard emotional testimony from Ms. Scharf-Lurie and others who think that the Lyme vaccine made them or their family members sick. What they didn't hear, either from the company or from the FDA, was sufficient scientific evidence to settle the question of whether the vaccine caused the illnesses, Mr. Daum said.

"Your heart went out to these folks who came" to testify, he said. "And yet, where's the science? The committee was presented with what they thought was less than the science that they had hoped for – from everybody."

More than 16,000 cases of Lyme disease were reported in 1999, making it the most common illness transmitted by insects, ticks or spiders in the United States. Yet, most cases are concentrated in about 115 counties in the eastern and north-central United States where animals [chiefly mice and deer] have high infection rates with the disease-causing bacteria, increasing the likelihood that a tick bite will transmit the infection to humans.

GlaxoSmithKline has marketed the vaccine aggressively, with advertisements presenting ticks as a threat to people in many states who garden, golf or cook on the outdoor barbecue.

However, the vaccine – which costs about $200 for a series of three doses – does not provide complete protection, and recent studies suggest that periodic boosters are needed to maintain immunity. Only people living in high-risk areas who engage in high-risk activities, according to guidelines issued by the Centers for Disease Control and Prevention should consider it.

Ms. Hogan said the company's view on who should get the Lyme vaccine "is that people who live, work or travel in endemic areas should consider it."